Business · 16/12/2008
FDA Releases Draft Guidance on Genotoxic and Carcinogenic Impurities in Pharmaceuticals
The FDA has published a draft guidance document outlining recommended approaches for evaluating and managing genotoxic and carcinogenic impurities in pharmaceuticals, with the goal of improving the safety of these products during clinical development and marketing.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →